| CTRI Number |
CTRI/2022/05/042613 [Registered on: 18/05/2022] Trial Registered Prospectively |
| Last Modified On: |
08/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy and safety of Levonadifloxacin versus Teicoplanin-Azithromycin combination in hospitalized patients with Community Acquired Bacterial Pneumonia (CABP) |
|
Scientific Title of Study
|
A Prospective, Open label, Randomized, Comparative, Two arm, Multi-centric, Investigator initiated study to evaluate efficacy and safety of Levonadifloxacin with Teicoplanin-Azithromycin combination in hospitalized patients with Community Acquired Bacterial Pneumonia (CABP) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CABP/01/21, Version: 01, Date: 10 Dec 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anand Nikalje |
| Designation |
Director and In Charge ICU |
| Affiliation |
MGM Medical College and Hospital |
| Address |
7th Floor, Department of Medicine, Gate No. 2 , MGM Campus, N-6,CIDCO.,
City: Aurangabad, State: Maharashtra
Aurangabad
MAHARASHTRA
431 003
India |
| Phone |
|
| Fax |
|
| Email |
anandnikalje@rediffmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Pramit Sonone |
| Designation |
Senior Manager Clinical Operations and PV |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra – 400 051, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596447 |
| Fax |
|
| Email |
PSonone@wockhardt.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Khokan Debnath |
| Designation |
Head of Clinical Operations, Regulatory Affairs & PV, Medical Affairs |
| Affiliation |
Wockhardt Ltd. |
| Address |
Wockhardt Towers, Bandra Kurla Complex, Bandra – 400 051, Mumbai
Mumbai
MAHARASHTRA
400051
India |
| Phone |
02226596407 |
| Fax |
|
| Email |
kdebnath@wockhardt.com |
|
|
Source of Monetary or Material Support
|
| Wockhardt Ltd.
Wockhardt Towers, Bandra – Kurla Complex, Bandra East, Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Anand Nikalje |
| Address |
MGM Medical College and Hospital
Gate No. 2 , MGM Campus, N-6,CIDCO.,
City: Aurangabad, State: Maharashtra.
Pincode: 431 003
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 10 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shirkant Deshpande |
Ashirwad Hospital |
Out Patient Department, Ground Floor, Next to 32 Maratha section, Krishna Nagar, Ulhasnagar 421004, Thane
Thane
MAHARASHTRA
Thane
MAHARASHTRA |
9822017445
writetoshrikant@rediffmail.com |
| Dr Rahul Kumar Rathore |
Charak Hospital and Research Centre |
2nd Floor, Department of Pulmonary Medicine
Hardoi Rd, near Safaid Masjid, Dubagga, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
7408441522
drrahulkgmu85@gmail.com |
| Dr Shubhangi Deshpande |
GMERS Medical College and General Hospital |
6th floor, Department of Medicine, Old TB hospital Campus, Gotri Rd, Gotri, Vadodara Gujarat 390021
Vadodara
GUJARAT
Vadodara
GUJARAT |
7878081208
Shubhangi311@yahoo.com |
| Dr Chintan Patel |
Hansa Clinic and Hospital |
Ground Floor, Department of Pulmonary, AMALIA DABHEL, Vapi Daman Road, Somnath, Daman, Daman and Diu 396215
Daman
DAMAN & DIU
Daman
DAMAN & DIU |
9909012179
hansahospital@gmail.com |
| Dr Mohammad Shafat Imam Siddiqui |
Heritage Institute of Medical Sciences |
NH-2 (GT Road-Bypass), Varanasi 221311, Uttar Pradesh
Varanasi
UTTAR PRADESH |
9889352598
drshafaatimam@gmail.com |
| Dr Madhusudan R Jaju |
KIMS Hospitals |
45, Survey No. 40 46, 7-56/19, Dargah Road, LIG Chitrapuri colony, Prashant Hills, Gachibowli, Telangana 500032
Hyderabad
TELANGANA |
9440379476
madhu_jaju123@rediffmail.com |
| Dr Balaji More |
Mahatma Gandhi Medical College and Research Institute, Puducherry |
Pondicherry-Cudalore Road, ECR, Pillayarkuppam, Puducherry 607402, India
Pondicherry
PONDICHERRY |
8452959225
pending@gmail.com |
| Dr Anand Nikalje |
MGM Medical College and Hospital, Aurangabad |
7th Floor, Department of Medicine, Gate No. 2 , MGM Campus, N-6,CIDCO.,
City: Aurangabad, State: Maharashtra. Pincode: 431 003
Aurangabad
MAHARASHTRA |
9822496190
anandnikalje@rediffmail.com |
| Dr Manimaran |
MIOT International Hospitals |
1st Floor, Department of Pulmonology , 4/112, Mount Poonamallee Road|Manapakkam|Chennai-600 089
Chennai
TAMIL NADU |
9789888442
doctormmm@gmail.com |
| Dr Kapil Zirpe |
Ruby Hall Clinic |
Neuro Critical Care, 40, Sassoon Road, Pune – 411001, Maharashtra, India
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9822844212
kapilzirpe@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committee |
Approved |
| HCH Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Heritage Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Poona Medical Research Foundation |
Approved |
| Institutional Ethics Committee, Charak Hospital & Research Centre |
Approved |
| Institutional Human Ethics Committee GMERS Vadodara |
Submittted/Under Review |
| KIMS Ethics Committee |
Not Applicable |
| MGM ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECT |
Submittted/Under Review |
| MIOT International Hospitals Institutional Ethics Committee |
Approved |
| The Institutional Human Ethics Committee (IHEC) of Mahatma Gandhi Medical College & Research Institute, Puducherry (MGMCRI) |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J159||Unspecified bacterial pneumonia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Azithromycin 500mg |
Azithromycin will be administered 500 mg oral/ intravenous once a day upto 14 days |
| Intervention |
Levonadifloxacin Injection 800 mg
|
Levonadifloxacin IV 800 mg will be administered twice in a day 11±1 hours apart. One dose of IP will be infused over a period of approximately 90 mins.
|
| Intervention |
Levonadifloxacin tablet 500 mg |
Levonadifloxacin Oral 1000 mg will be administered twice in a day, 11±1 hours apart upto 14 days |
| Comparator Agent |
Teicoplanin 400 mg |
Teicoplanin will be administered 400 mg (approx. 6 mg/kg body weight) every 12 hours for initial 3 intravenous/ intramuscular administration as loading dose. Teicoplanin will be administered 400 mg (approximately 6 mg/kg body weight) intravenous/ intramuscular administration once a day as maintenance dose
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult subjects of any gender ≥18 years
Subjects must be willing to participate in the study and provide a written informed consent
Subjects with diagnosed CABP (requiring hospitalization) characterized by
At least two of the following
Cough
Production of purulent sputum
Dyspnea (shortness of breath)
Pleuritic chest pain
At least two of the following
Fever or hypothermia temperature > 38° C (100.4° F) or < 36 C (95.5° F).
Hypotension with systolic blood pressure (SBP) < 90 mmHg.
Heart rate > 90 beats/min
Respiratory rate (RR) > 20 breaths/min
At least one of the following
Hypoxemia {partial pressure of arterial oxygen (PaO2)} < 60 mmHg by arterial blood gas (ABG)
Physical examination findings of pulmonary consolidation (e.g. dullness on percussion, bronchial breath sounds or egophony)
An elevated total white blood cell (WBC) count (>12,000 cells/mm3) or leucopenia (WBC < 4000 cells/mm3)
Radiographically confirmed pneumonia, i.e. new or progressive pulmonary infiltrate on chest X-ray (CXR) or chest computed tomography (CT) scan consistent with bacterial pneumonia
PSI - PORT Risk Class > II
|
|
| ExclusionCriteria |
| Details |
The Patients must not meet any the following criteria:
Subjects with history of hypersensitivity to any of the study drugs or same class of drugs
Subject who have received prior Azithromycin therapy for the treatment of a current episode of CABP.
Subjects who have received prior antibiotic therapy within the past 24 hours for the treatment of a current episode of CABP. Following are the exception to these criteria:
Subjects who have received a single dose of short acting antibacterial drug within 24 hours of enrolment
Subjects with evidence of clinical progression of CABP while on antibacterial drug therapy after at least 48 hours
Subjects who have received an antibacterial drug for surgical prophylaxis and subsequently developed CABP
Subjects who received any experimental drug within 30 days prior to enrolment
Subjects who, in the judgment of the Investigator, are likely to be noncompliant or uncooperative during the study
Subjects with any abnormality that the Investigator deems to be clinically relevant, either on medical history, systemic examination or ECG
Subjects on hemodialysis or creatinine clearance ≤ 30 mL/min (estimated by Cockcroft Gault equation).
Subjects with abnormal platelet count < 1,50,000 cells/mm3
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical success rate at TOC (Test of Cure) visit |
Day 7±1 to 14 from initiation of therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical success rate at EOT (End of Treatment) visit i.e. Day 7±1 to 14
Clinical improvement rate at visit 2 (Early Assessment visit) i.e. Day 4±1 from initiation of therapy
Microbiological success rate at EOT (End of Treatment) visit
Safety – Tolerability Endpoint: Incidence of adverse events / serious adverse events, Incidence of Nephrotoxicity & Incidence of Thrombocytopenia
|
Day 7±1 to 14
Day 4±1 from initiation of therapy
Throughout the study
|
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/05/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Prospective, Open label,
Randomized, Comparative, Two arm, Multi-centric, Investigator initiated study
in hospitalized patients of Community Acquired Bacterial Pneumonia (CABP).
This study aims to evaluate efficacy
and safety of Levonadifloxacin and Teicoplanin-Azithromycin combination in
hospitalized patients with Community Acquired Bacterial Pneumonia (CABP)
Minimum Duration of treatment will be 5
days. (Duration of treatment can be extend upto 14 days as per investigator’s
discretion.)
Primary endpoint - Clinical success
rate at TOC (Test of Cure) visit
Secondary Endpoint –
i.
Clinical success rate at EOT (End of
Treatment) visit
ii.
Clinical improvement rate at visit 2
(Early Assessment visit)
iii.
Microbiological success rate at EOT
(End of Treatment) visit
Safety – Tolerability Endpoint: Incidence of adverse events / serious
adverse events, Incidence of Nephrotoxicity & Incidence of Thrombocytopenia |